Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045682
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2002-09-06
Brief Title:
CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of polyglutamate paclitaxel CT-2103 as third-line treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer
II Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive polyglutamate paclitaxel CT-2103 IV over 10-20 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Determine the antitumor activity of polyglutamate paclitaxel CT-2103 as third-line treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer
II Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive polyglutamate paclitaxel CT-2103 IV over 10-20 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02493 | REGISTRY | None | None |
| CDR0000257039 | None | None | None |
| GOG-0186C | OTHER | None | None |
| GOG-0186C | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |